BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-SMART

    MDR report key: 1833142 · Received September 9, 2010

    Report

    Report Number
    8031010-2010-00120
    Event Type
    Injury
    Date Received
    September 9, 2010
    Report Date
    August 11, 2010
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WE
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVAL OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED AND THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN X-SMART ENDO UNIT FAILED TO AUTO-REVERSE PROPERLY, POSSIBLY CAUSING A FILE TO SEPARATE. THE TOOTH WAS EXTRACTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-SMART EKX DENTSPLY MAILLEFER

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention